Adding Failure Codes to a CAPA
You can add failure codes on a CAPA by adding an FMEA object or manually adding a reported experienced effect.
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The QMS - Failure Codes - Display Pick FMEA Action preference controls if this functionality is enabled. This preference is set to true for new installations. It is set to false for upgrades and updates.
By default, the Display Types in Failure Codes Tables preference is set to false. For the Failure Mode Type, Failure Effect Type, and Harm Hazard Type columns to appear in the Failure Codes table, set this preference to true. This preference only applies to editable tables for adding FMEA objects and dynamic records. Use views to configure viewable tables.
Administrators must manually add access control permissions for users to create, modify, or delete FMEA objects.
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1. In the Affected Objects table, in the New CAPA Request window, add objects as needed. Click the edit details icon 
in the added object row.
in the added object row.◦ To add a reported experienced effect, in the Edit Details window, in the Failure Codes table, click the Add Reported Experienced Effects icon 
. The system adds a blank row to the Failure Codes table.
. The system adds a blank row to the Failure Codes table.◦ To add an existing FMEA, do the following:
1. In the Edit Details window, in the Failure Codes table, click the Pick FMEA icon 
. The Select FMEA window opens.
. The Select FMEA window opens.2. In this window, search for the FMEA that relates to the part.
3. Select the FMEA from the Search Results table and click OK. Attributes from the FMEA object appear in the Failure Codes table.
2. Enter or edit the FMEA information:
Field | Description | ||
|---|---|---|---|
State | The system completes this field with the state of the CAPA when the effect was added. | ||
Affected Part | This field defaults to the part that the effect is related to. Click the find icon  . Select a part from the Failure Modes window and click OK. | ||
Failure Mode | The name of the selected failure mode. Click the find icon . Select an object type from the Affected Part window and click OK. | ||
Failure Effect | The name of the selected failure effect. Click the find icon . Select an object type from the Failure Effect window and click OK. | ||
Severity | Enter the suggested severity of the selected effect. | ||
Harm Hazard | The name of the selected harm hazard. Click the find icon . Select an object type from the Harm Hazard window and click OK. | ||
Comment | Enter comments about the failure code. | ||
Lessons Learned | The name of the selected item. Click the find icon . Select an object from the Select window and click OK. To remove information from the field and leave it blank, click the clear icon  .
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Confirmed | Specifies if the added failure is confirmed.
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| | • You can only edit the fields from the add FMEA icon during the Intake state. If an investigator receives more details about an effect during the Investigation state, the investigator must copy the effect from the Intake state and make changes to the copy. This allows the system to retain the history of the effect from the Intake state.• You can edit fields from the add reported experienced effect icon during the Intake, Investigation and Effectiveness states.• When visible, the Lessons Learned and Confirm fields can be edited regardless of the state their effect was created. • You cannot remove effects that were entered during a different state. • When visible, the Failure Mode Type, Failure Effect Type, and Harm Hazard Type columns show the type information for a failure effect, failure mode, or harm hazard. These fields are not editable, but they change when a failure effect, failure mode, or harm hazard is selected. |
Actions on Failure Codes Table
Actions | Description |
|---|---|
| Adds the FMEA object. |
| Adds reported experienced effects. |
 | Removes the FMEA object. |
 | Adds a duplicate failure code. Select the row with the failure code and click icon to create a duplicate failure code. You can edit the information in the new row as needed. |
Viewing Failure Code Information
• To access failure codes on the Structure tab of the CAPA Information Page, under Affected Objects, select a part to view the tables on the right side of the page below Affected Object Details section.
• To access failure codes on the Structure tab of the Affected Object table, click the view details icon 
to access the View Details window.
to access the View Details window.• To access failure codes on the CAPA Management tab of the Affected Object table, click the view details icon to access the View Details window.
to access the View Details window.• To access failure codes on the CAPA Management tab of the CAPA information page, click the edit affected object icon to access the Edit Affected Object window.
to access the Edit Affected Object window.Working with FMEA Objects on a Part
To view the FMEA table, on the part information page, select > > .
To edit an FMEA object, right-click the FMEA object and select Edit FMEA. Complete the necessary fields and click OK.